ABSTRACT ? CLINICAL PROTOCOL AND DATA MANAGEMENT Part I: Clinical Protocol and Data Management The primary mission of the CCTO is to assist the Tisch Cancer Institute Investigators in the development, conduct, and reporting of innovative clinical research in an efficient, compliant and scientifically sound manner. The CCTO is composed of regulatory, financial, clinical, study management, compliance programs, data management and reporting that provide uniformity and consistency in clinical research by supporting investigators. There is a Quality Assurance Program (QAP) responsible for centralized education and training services, subject central registration, auditing, development of policy and supports the TCI Data and Safety Monitoring Committee (DSMC). The CCTO also provides a central location for cancer protocols, a centralized database of protocol-specific data, and an updated list of active protocols. Part II: Data and Safety Monitoring All cancer clinical trials are monitored according to the guidelines set forth in the TCI Data and Safety Monitoring Plan (DSMP). A formal Data and Safety Monitoring Committee (DSMC) was established to ensure that all clinical trials in the TCI have an adequate data and safety monitoring plan commensurate with level of risk. Part III: Inclusion of Women and Minorities The Mount Sinai Medical Center is uniquely juxtaposed between three culturally, ethnically, and economically distinct neighborhoods: the Upper East Side is predominately white, East Harlem predominately Hispanic and Black and Central Harlem predominantly Black and Hispanic. In addition, TCI clinicians provide medical care, and TCI investigators are engaged in ongoing research, for the unique World Trade Center (WTC) cohort. These four components comprise the TCI catchment area and are a principal focus of our clinical, basic and population sciences research initiatives. Part IV: Inclusion of Children in Clinical Research Pediatric cancer care is provided through the Jack Martin Division of Pediatric Hematology-Oncology, where Mount Sinai is a full member of the Children's Oncology Group (COG). A full complement of therapeutic options including allo- and auto- stem cell transplantation are available through the FACT-accredited stem cell therapy program.